Market Newsdesk

RALEIGH, N.C. , April 07, 2021 (GLOBE NEWSWIRE) — PRA Health Sciences (NASDAQ: PRAH) announced today that Merck KGaA, Darmstadt, Germany, known in the United States as EMD Serono, selected PRA’s remote patient monitoring platform to work in combination with its human growth hormone (HGH) treatment system. Under this agreement, PRA’s remote patient monitoring platform backs Merck KGaA, Darmstadt, Germany’s HGH treatment system, including growlink^TM, a mobile app for patients prescribed with HGH treatment, and easypod® Connect, a secure platform for healthcare professionals (HCP) in the field of endocrinology to monitor patients’ adherence, review injection history, and share information about patients’ progression with growth hormone disorder.

“Patients and payers expect us to offer new technologies, such as treatment-supporting apps, with the highest levels of privacy and data security,” said Andre Musto, Senior Vice President and Head of Cardiovascular Metabolism & Endocrinology, Merck KGaA, Darmstadt, Germany. “With growlink and easypod Connect, supported by PRA’s remote patient monitoring platform, we can offer patients innovative tools to help manage their condition and assure payers of the effective use of treatments while fully respecting their privacy and data security.”

Human growth hormone treatments are frequently prescribed for children and adolescents with growth hormone deficiency, a condition that impacts approximately 1:4,000 to 1:10,000 children¹ each year in the U.S. Despite the prevalence of growth hormone deficiency and treatment options, one of the biggest challenges is ensuring patients’ adherence to the regimen. Adding this layer of technology to HGH treatments better facilitates patient engagement, helps HCPs make better use of patient visits, and ensures the treatment is taken regularly and at the right dosage, optimizing treatment outcome and driving payer confidence.

In a real-world setting, an HCP would use easypod Connect to invite patients to download the mobile app, growlink. Then the patient downloads the mobile app, signs an eConsent form on the app, and syncs the app with Merck KGaA, Darmstadt, Germany’s HGH injector medical device, easypod. This device is able to self-regulate the appropriate dosage of HGH based on the treatment protocol. The four-part system – Merck KGaA, Darmstadt, Germany’s mobile app (growlink), connected device (easypod), and HCP platform (easypod Connect ) underpinned by PRA’s remote patient monitoring technology – enables HCPs to see an accurate picture of patients’ adherence, height, weight, and other outcomes while offering patients a more convenient way to follow to their treatment regimen and manage their condition.

“For many years, PRA has been focused on designing an end-to-end digital health platform that supports mobile healthcare delivery, such as remote patient monitoring,” said Kent Thoelke, Executive Vice President and Chief Scientific Officer, PRA Health Sciences. “Our collaboration with Merck KGaA, Darmstadt, Germany to support growlink and easypod Connect is an example of how the industry is advancing with the patient at the center of our innovation.”

PRA hosted a webinar called, How Digital Therapeutics and Remote Patient Monitoring Can Drive Pharmaceutical Product Differentiation, to help create differentiation. Access the replay webinar today.

For more information about PRA’s remote patient monitoring solutions, visit www.prahs.com.

¹ Stanley T. Diagnosis of Growth Hormone Deficiency in Childhood. HHS Public Access. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3279941/

About PRA Health Sciences

PRA Health Sciences is one of the world’s leading global contract research organizations by revenue, providing outsourced clinical development and data solution services to the biotechnology and pharmaceutical industries. PRA’s global clinical development platform includes more than 75 offices across North America, Europe, Asia, Latin America, Africa, Australia and the Middle East and more than 19,000 employees worldwide. Since 2000, PRA has participated in approximately 4,000 clinical trials worldwide. In addition, PRA has participated in the pivotal or supportive trials that led to U.S. Food and Drug Administration or international regulatory approval of more than 95 drugs. To learn more about PRA, please visit www.prahs.com.

INVESTOR INQUIRIES: [email protected]

MEDIA INQUIRIES: Laurie Hurst, Sr. Director, Communications and Public Relations
[email protected] | +1 (919) 786-8435

CytoDyn also negotiating the potential future delivery of 100,000 vials to the Philippines for additional CSP use

VANCOUVER, Washington, April 07, 2021 (GLOBE NEWSWIRE) — CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with potential multiple therapeutic indications, announced today it is delivering leronlimab to a Philippine hospital to be administered to an additional 28 critically ill COVID-19 patients under a new CSP. Chiral Pharma Corporation, CytoDyn’s commercial partner in the Philippines, is working closely with the Philippine FDA and the hospital.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “Based upon the speedy recovery of the first COVID-19 CSP patient in the Philippines, we are coordinating very closely with Chiral and the regulators to ensure we are expediting as much leronlimab as needed. We remain hopeful that all of these coordinated efforts will continue to expand the availability of leronlimab to the Philippines.”

About Leronlimab (PRO 140)

The U.S. Food and Drug Administration (FDA) granted CytoDyn Fast Track designation to explore two potential indications using leronlimab to treat HIV and metastatic cancer. The first indication is combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer (mTNBC). Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor important in HIV infection, tumor metastases, and other diseases, including NASH (Nonalcoholic Steatohepatitis). Leronlimab has been studied in 11 clinical trials involving more than 1,200 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab combined with standard antiretroviral therapies in HIV-infected treatment-experienced patients). 

Leronlimab is a viral-entry inhibitor in HIV/AIDS. It masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Nine clinical trials have demonstrated leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent with fewer side effects and less frequent dosing requirements than currently used daily drug therapies. 

Cancer research has shown CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. As a result, CytoDyn is conducting two Phase 2 human clinical trials, one in mTNBC, which was granted Fast Track designation by the FDA in 2019, and a second in a basket trial which encompasses 22 different solid tumor cancers.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. After completing two clinical trials with COVID-19 patients (a Phase 2 and a Phase 3), CytoDyn initiated a Phase 2 investigative trial for post-acute sequelae of SARS COV-2 (PASC), also known as COVID-19 Long-Haulers. This trial will evaluate the effect of leronlimab on clinical symptoms and laboratory biomarkers to further understand the pathophysiology of PASC. It is currently estimated that between 10-30% of those infected with COVID-19 develop long-term sequelae. Common symptoms include fatigue, cognitive impairment, sleep disorders, and shortness of breath. If this trial is successful, CytoDyn plans to pursue clinical trials to evaluate leronlimab’s effect on immunological dysregulation in other post-viral syndromes, including myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

CytoDyn is also conducting a Phase 2 clinical trial for NASH to evaluate the effect of leronlimab on liver steatosis and fibrosis. Preclinical studies revealed a significant reduction in NAFLD and a reduction in liver fibrosis using leronlimab. There are currently no FDA approved treatments for NASH. NASH is a leading cause of liver transplant. About 30 to 40 percent of adults in the U.S. live with NAFLD, and 3 to 12 percent of adults in the U.S. live with NASH.

About CytoDyn

CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications using leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.

CytoDyn has successfully completed a Phase 3 pivotal trial using leronlimab combined with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn has been working diligently to refile its Biologics License Application (“BLA”) for this HIV combination therapy since receiving a Refusal to File in July 2020 and subsequently meeting with the FDA telephonically to address their written guidance concerning the filing. CytoDyn expects to refile its BLA in the first half of the calendar year 2021 or shortly thereafter.

CytoDyn also completed a Phase 3 investigative trial with leronlimab used as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension approval. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce the viral burden in people infected with HIV. Moreover, a Phase 2 clinical trial demonstrated that leronlimab monotherapy could prevent viral escape in HIV-infected patients; several patients on leronlimab’s Phase 2 monotherapy extension arm have remained virally suppressed for more than six years. There have been no strong safety signals identified in patients administered leronlimab in multiple disease spectrums, including patients with HIV, COVID-19 and Oncology.

CytoDyn is also conducting a Phase 2 clinical trial with leronlimab in mTNBC, a Phase 2 basket trial in solid tumor cancers (22 different cancer indications), Phase 2 investigative trial for post-acute sequelae of SARS COV-2, also known as COVID-19 Long-Haulers, and a Phase 2 clinical trial for NASH. CytoDyn has already completed two trial in COVID-19 patients (a Phase 2 and a Phase 3) and is in the process of conducting an additional COVID-19 Phase 3 trial for mechanically ventilated critically ill COVID-19 patients. More information is at www.cytodyn.com. 

Forward-Looking Statements 

This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as “believes,” “hopes,” “intends,” “estimates,” “expects,” “projects,” “plans,” “anticipates” and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to provide positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Company’s forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company’s cash position, (ii) the Company’s ability to raise additional capital to fund its operations, (iii) the Company’s ability to meet its debt obligations, if any, (iv) the Company’s ability to enter into partnership or licensing arrangements with third parties, (v) the Company’s ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company’s ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company’s clinical trials, (viii) the results of the Company’s clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company’s products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company’s control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CONTACTS

Investors:

Michael Mulholland
Office: 360.980.8524, ext. 102
[email protected]

STAMFORD, Conn., April 07, 2021 (GLOBE NEWSWIRE) — Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs, today announced that Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer, will participate in a fireside chat at the 20th Annual Needham Healthcare Conference on Wednesday, April 14, 2021 at 2:15 p.m. ET.

A live webcast of the presentation can be accessed under “Events & Presentations” in the News & Investors section of the Company’s website at www.CaraTherapeutics.com. An archived webcast recording will be available on the Cara website for approximately 30 days.

About Cara Therapeutics

Cara Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs. Cara is developing a novel and proprietary class of product candidates, led by KORSUVA™ (CR845/difelikefalin), a first-in-class KOR agonist that targets the body’s peripheral nervous system, as well as certain immune cells. In two Phase 3 trials, KORSUVA Injection has demonstrated statistically significant reductions in itch intensity and concomitant improvement in quality of life measures in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP). The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the New Drug Application (NDA) for KORSUVA™ (difelikefalin) solution for injection for the treatment of moderate-to-severe pruritus in hemodialysis patients. The PDUFA target action date for KORSUVA is August 23, 2021. Oral KORSUVA™ has successfully completed a Phase 2 trial for the treatment of pruritus in patients with CKD and is currently in Phase 2 trials in atopic dermatitis, primary biliary cholangitis and notalgia paresthetica patients with moderate-to-severe pruritus.

The FDA has conditionally accepted KORSUVA™ as the trade name for difelikefalin solution for injection. Difelikefalin is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

MEDIA CONTACT:

Claire LaCagnina
6 Degrees
315-765-1462
[email protected]

INVESTOR CONTACT:

Janhavi Mohite
Stern Investor Relations, Inc.
[email protected]

RECORLEV^® (levoketoconazole) Treatment Demonstrates Clinically Meaningful Improvements in Cortisol Control and Clinical Benefit in Patients with Cushing’s Syndrome and Comorbid Diabetes Mellitus

DUBLIN, Ireland and TREVOSE, Pa., April 07, 2021 (GLOBE NEWSWIRE) — Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced that results from a subanalysis of patients with diabetes mellitus from the Phase 3 SONICS study of RECORLEV^® (levoketoconazole) for the potential treatment of endogenous Cushing’s syndrome were published in the peer-reviewed journal, Frontiers in Endocrinology.

“Diabetes mellitus is among the more common complications related to excess levels of cortisol in people with Cushing’s syndrome,” said Fredric Cohen, M.D., chief medical officer of Strongbridge Biopharma. “The SONICS study results provide important evidence that help further characterize the potential clinical benefit and role of RECORLEV as an important treatment option for patients with Cushing’s syndrome.”

The manuscript, entitled “Levoketoconazole in the Treatment of Patients with Cushing’s Syndrome and Diabetes Mellitus: Phase 3 SONICS Results,” demonstrates that treatment with RECORLEV results in significant cortisol control in patients with Cushing’s syndrome and diabetes mellitus, as well as meaningful improvements in key glycemic measures, such as hemoglobin A1c (HbA1c) and fasting blood glucose (FBG), and cardiovascular risk markers such as low-density lipoprotein (LDL)-cholesterol. These results were observed following a dose titration phase and a six-month maintenance phase.

• Mean urinary-free cortisol (mUFC) normalization rate was similar in patients with and without diabetes at the end of the maintenance phase.
• Mean improvements in HbA1c and FBG in the maintenance phase were more meaningful among patients with comorbid diabetes mellitus than in those without. These improvements in glycemia markers were not due to changes in antidiabetic medication use, which were overall stable during treatment.
• Significant mean reductions from baseline, representing improvement in cardiovascular risk markers of LDL-cholesterol, weight, and body mass index were seen in patients with and without diabetes mellitus.
• Adverse events that were more common in patients with diabetes mellitus included nausea (58.3%), vomiting (19.4%), and urinary tract infection (16.7%); none prompted study drug withdrawal. As noted in the Phase 3 SONICS results published in The Lancet Diabetes & Endocrinology, nausea and headache were the most common adverse events in the overall study population. These events rarely affected treatment and did not appear to be dose related.

These results were previously presented in part at the 2019 Annual Meeting of the Endocrine Society (ENDO), held March 23 – 26, in New Orleans, Louisiana. The poster, entitled Results from the Phase 3 Multicenter SONICS Study of Levoketoconazole: Subgroup Analysis of Cushing’s Syndrome in Patients with Diabetes Mellitus, can be accessed here.

About Cushing’s Syndrome

Endogenous Cushing’s syndrome, is a rare, serious and potentially lethal endocrine disease caused by chronic elevated cortisol exposure – often the result of a benign tumor of the pituitary gland. This benign tumor tells the body to overproduce high levels of cortisol for a sustained period of time, and this often results in undesirable physical changes. The disease is most common among adults between the ages of 30 to 50, and it affects women two times more often than men. Women with Cushing’s syndrome may experience a variety of health issues including menstrual problems, difficulty becoming pregnant, excess male hormones (androgens), primarily testosterone which can cause hirsutism (growth of coarse body hair in a male pattern), oily skin, and acne. Additionally, the internal manifestations of the disease are potentially life threatening. These include metabolic changes such as high blood sugar, or diabetes, high blood pressure, high cholesterol, fragility of various tissues including blood vessels, skin, muscle and bone, and psychologic disturbances such as depression, anxiety and insomnia. Untreated, the five-year survival rate is only approximately 50 percent.

About the SONICS Study

SONICS is an open-label, Phase 3 study of RECORLEV as a treatment for endogenous Cushing’s syndrome that enrolled 94 patients at centers in North America, Europe and the Middle East. Following a screening phase, SONICS has three treatment phases:

(1) Dose Titration Phase: Patients started RECORLEV at 150 mg twice daily (300 mg total daily dose) and titrated in 150 mg increments with the goal of achieving a therapeutic dose – a dose resulting in mUFC normalization – at which point titration was stopped; (2) Maintenance Phase: The dose was fixed and should not have been changed other than for safety reasons or loss of efficacy. At the end of the six-month maintenance phase, the mUFC response rate was measured; and (3) Extended Evaluation Phase: Patients continued on RECORLEV for another six months to evaluate long-term safety and tolerability and explore efficacy durability.

About RECORLEV

RECORLEV^® (levoketoconazole) is an investigational cortisol synthesis inhibitor in development for the treatment of patients with endogenous Cushing’s syndrome, a rare but serious and potentially lethal endocrine disease caused by chronic elevated cortisol exposure. RECORLEV is the pure 2S,4R enantiomer of ketoconazole, a steroidogenesis inhibitor. RECORLEV has demonstrated in two successful Phase 3 studies to significantly suppress serum cortisol and has the potential to be a next-generation cortisol inhibitor.

The Phase 3 program for RECORLEV includes SONICS and LOGICS: two multinational studies designed to evaluate the safety and efficacy of RECORLEV when used to treat endogenous Cushing’s syndrome. The SONICS study met its primary and secondary endpoints, demonstrating a statistically significant normalization rate of urinary free cortisol at six months. The LOGICS study, which met its primary endpoint, is a double-blind, placebo-controlled randomized-withdrawal study of RECORLEV that is designed to supplement the long-term efficacy and safety information supplied by SONICS. The ongoing long-term open label OPTICS study will gather further useful information related to the long-term use of RECORLEV.

RECORLEV has received orphan drug designation from the FDA and the European Medicines Agency for the treatment of endogenous Cushing’s syndrome.

About Strongbridge Biopharma

Strongbridge Biopharma is a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs. Strongbridge’s rare endocrine franchise includes RECORLEV^® (levoketoconazole), a cortisol synthesis inhibitor currently being studied in Phase 3 clinical studies for the treatment of endogenous Cushing’s syndrome, and veldoreotide extended release, a pre-clinical next-generation somatostatin analog being investigated for the treatment of acromegaly and potential additional applications in other conditions amenable to somatostatin receptor activation. Both RECORLEV and veldoreotide have received orphan drug designation from the FDA and the European Medicines Agency. The Company’s rare neuromuscular franchise includes KEVEYIS^® (dichlorphenamide), the first and only FDA-approved treatment for hyperkalemic, hypokalemic, and related variants of primary periodic paralysis. KEVEYIS has orphan drug exclusivity in the United States.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the federal securities laws. The words “anticipate,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “project,” “target,” “will,” “would,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. All statements, other than statements of historical facts, contained in this press release, are forward-looking statements, including statements related to the subgroup analysis data from the SONICS study, the potential advantages of RECORLEV,  Strongbridge’s strategy, plans, outcomes of product development efforts and objectives of management for future operations. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed in such statement, including risks and uncertainties associated with clinical development and the regulatory approval process, the reproducibility of any reported results showing the benefits of RECORLEV, the adoption of RECORLEV by physicians, if approved, as treatment for any disease and the emergence of unexpected adverse events following regulatory approval and use of the product by patients.  Additional risks and uncertainties relating to Strongbridge and its business can be found under the heading “Risk Factors” in Strongbridge’s Annual Report on Form 10-K for the year ended December 31, 2020 and its subsequent Quarterly Reports on Form 10-Q, as well as its other filings with the SEC. These forward-looking statements are based on current expectations, estimates, forecasts and projections and are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors. The forward-looking statements contained in this press release are made as of the date of this press release, and Strongbridge Biopharma does not assume any obligation to update any forward-looking statements except as required by applicable law.

Contacts:

Corporate and Media Relations

Elixir Health Public Relations
Lindsay Rocco
+1 862-596-1304
[email protected]

Investor Relations

Solebury Trout
Mike Biega
+1 617-221-9660
[email protected]